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Article ; Online: Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic

Daniel E. Ford / Ann Johnson / Jason J. Nichols / Erin Rothwell / Steve Dubinett / Arash Naeim

Journal of Clinical and Translational Science, Vol

2021 Volume 5

Abstract: The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review ... ...

Abstract	The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.
Keywords	Internal review board ; COVID-19 ; informed consent ; protocol review ; protection of human subjects ; Medicine ; R
Subject code	306
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: 2553 Authors’ perceptions of the interdisciplinarity of their research

Christine M. Weston / Mia S. Terkowitz / Daniel E. Ford

Journal of Clinical and Translational Science, Vol 2, Pp 5-

2018 Volume 5

Abstract: OBJECTIVES/SPECIFIC AIMS: The objectives of this study were to compare different methods for determining the disciplines involved in a research article. We sought to address the following questions: To what extent does the number of disciplines reported ... ...

Abstract	OBJECTIVES/SPECIFIC AIMS: The objectives of this study were to compare different methods for determining the disciplines involved in a research article. We sought to address the following questions: To what extent does the number of disciplines reported by an article’s corresponding author agree with their description of the article as unidisciplinary or interdisciplinary? (Q1) and To what extent does the corresponding author’s description of the research as unidisciplinary or interdisciplinary agree with its classification as unidisciplinary or interdisciplinary based on the affiliation of its co-authors? (Q2). METHODS/STUDY POPULATION: Using Scopus, we randomly selected 100 articles from 2010 and 2015 from science teams that had at least 1 author affiliated with Johns Hopkins. Author affiliations were grouped into common academic disciplines: Basic Science, Medicine (and all clinical specialties), Public Health, Engineering, Social Science, Computer Science, Pharmacy, Nursing, and Other. Articles with more than 1 discipline were considered, interdisciplinary. We then sent an online Qualtrics survey to the corresponding author of each article and asked them to indicate (1) all of the disciplines that contributed to the research article at hand, and (2) to indicate whether they considered the research to be “unidisciplinary” or “interdisciplinary” based on definitions that we provided. RESULTS/ANTICIPATED RESULTS: For Q1, we asked corresponding authors to indicate the number of disciplines involved in their research and then to choose the definition that best described their research. Among 76 respondents, 42 indicated that their research consisted of 1 discipline, and 34 indicated that their research consisted of more than 1 discipline. Of the 42 respondents who indicated that their research consisted of one discipline, 21 (50%) respondents described their research as “unidisciplinary” and 21 (50%) described their research as “interdisciplinary.” However, of the 34 respondents who indicated that their research ...
Keywords	Medicine ; R
Subject code	001
Language	English
Publishing date	2018-06-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: 2494

Christine M. Weston / Mia S. Terkowitz / Daniel E. Ford

Journal of Clinical and Translational Science, Vol 1, Pp 51-

2017 Volume 51

Abstract: OBJECTIVES/SPECIFIC AIMS: The purpose of this study is to determine if the prevalence of interdisciplinary collaborations has increased over the past 10 years at 1 CTSA-funded institution. METHODS/STUDY POPULATION: We used Scopus to identify all articles ...

Abstract	OBJECTIVES/SPECIFIC AIMS: The purpose of this study is to determine if the prevalence of interdisciplinary collaborations has increased over the past 10 years at 1 CTSA-funded institution. METHODS/STUDY POPULATION: We used Scopus to identify all articles published by authors affiliated with any of the Johns Hopkins Institutions for the years 2005, 2010, and 2015. We limited the search by the Scopus Field Codes “Subject Area” to biomedical science only, “Document Type” to articles only, and “Source Type” to journals only. We further eliminated all articles with 1 author or more than 10 authors. This resulted in 2800 articles for 2005, 3987 for 2010, and 4569 for 2015. After exporting the articles, we randomly selected 25 from each of the 3 time periods. Using the World Public Library Outline of Academic Disciplines as a guide, every author was assigned 1 of the following disciplines: Social Science (eg, Psychology), Basic Science (eg, Biology, Chemistry), Agriculture, Computer Science, Engineering, Medicine, Public Health, Nursing, or an Interdisciplinary field (eg, Genetic Medicine) based on their department and school affiliation. Articles with authors who belonged to 1 discipline only were considered single-discipline articles, and articles with authors in a least 2 different disciplines were considered “interdisciplinary.” RESULTS/ANTICIPATED RESULTS: Based on the results of an initial pilot study, in 2005, 24% of articles were interdisciplinary, in 2010, 20% of articles were interdisciplinary, and in 2015, 60% of articles were interdisciplinary. The large gap between the first 2 time periods (2005 and 2010) and the most recent (2015), suggests a possible pattern of increasing growth of interdisciplinary collaborations over time. Expanding this analysis to a much larger sample size will provide additional important evidence. DISCUSSION/SIGNIFICANCE OF IMPACT: Increasing emphasis is being placed on evaluating the effectiveness of the CTSA consortium in achieving its goals and on developing methods to gauge its ...
Keywords	Medicine ; R
Subject code	001
Language	English
Publishing date	2017-09-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

Ann R. Johnson / Megan Kasimatis Singleton / Julie Ozier / Emily Serdoz / Jennifer G. Beadles / Janelle Maddox-Regis / Sarah Mumford / Jeri Burr / J. Michael Dean / Daniel E. Ford / Gordon R. Bernard

Journal of Clinical and Translational Science, Vol

2022 Volume 6

Abstract: The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has ...

Abstract	The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
Keywords	IRB ; Single IRB ; Human Research Protection ; Reliance agreement ; Local context ; Medicine ; R
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Using gamification to enhance clinical trial start-up activities

Karen Lane / Ryan Majkowski / Joshua Gruber / Daniel Amirault / Shannon Hillery / Cortney Wieber / Dixie D Thompson / Jacqueline Huvane / Jordan Bridges / E. Paul Ryu / Lindsay M. Eyzaguirre / Marianne Gildea / Richard E. Thompson / Daniel E. Ford / Daniel Hanley

Journal of Clinical and Translational Science, Vol

2022 Volume 6

Abstract: Abstract Background: The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of ... ...

Abstract	Abstract Background: The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community. Methods: The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance. Results: Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second. Conclusion: This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.
Keywords	Gamification ; clinical trials ; metrics ; Trial Innovation Network ; trial start-up ; Medicine ; R
Subject code	629
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Informed consent

Erin Rothwell / Donna Brassil / Marietta Barton-Baxter / Kimberly A. Brownley / Neal W. Dickert / Daniel E. Ford / Stephanie A. Kraft / Jennifer B. McCormick / Benjamin S. Wilfond

Journal of Clinical and Translational Science, Vol

Old and new challenges in the context of the COVID-19 pandemic

2021 Volume 5

Abstract: In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent ... ...

Abstract	In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.
Keywords	Informed consent ; COVID-19 ; pandemic ; clinical research ; CTSA ; Medicine ; R
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Response of the trial innovation network to the COVID-19 pandemic

Rachel G. Greenberg / Lori Poole / Daniel E. Ford / Daniel Hanley / Harry P. Selker / Karen Lane / J. Michael Dean / Jeri Burr / Paul Harris / Consuelo H. Wilkins / Gordon Bernard / Terri Edwards / Daniel K. Benjamin

Journal of Clinical and Translational Science, Vol

2021 Volume 5

Abstract: Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an ... ...

Abstract	Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods: The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned. Results: The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. Conclusions: Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
Keywords	Trial innovation network ; COVID-19 ; clinical trial ; SARS-CoV-2 ; CTSA ; Medicine ; R
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Streamlining the institutional review board process in pragmatic randomized clinical trials

Guillaume Marquis-Gravel / Holly Robertson / W. Schuyler Jones / Danielle Riley / Daniel E. Ford / David Crenshaw / Yvonne A. Joosten / Lindsey Rudov / Adrian F. Hernandez / Rachel Hess

Trials, Vol 22, Iss 1, Pp 1-

challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

2021 Volume 9

Abstract: Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) ... ...

Abstract	Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.
Keywords	Institutional review boards ; Ethics ; Pragmatic trials ; Informed consent ; Aspirin ; Cardiology ; Medicine (General) ; R5-920
Subject code	170
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network

Journal of Clinical and Translational Science, Vol

2023 Volume 7

Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

Abstract	Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
Keywords	Trial innovation network ; CTSA ; clinical trials ; clinical trial roadblocks ; innovation ; Medicine ; R
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Trial Innovation Network Liaison Team

Journal of Clinical and Translational Science, Vol

building a national clinical and translational community of practice

2023 Volume 7

Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

Abstract	In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Keywords	Trial Innovation Network ; CTSA ; clinical trials ; team science ; community of practice ; collaboration ; Medicine ; R
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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